No coercive action against sale of available banned FDC drugs: HC

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SME Times News Bureau | 19 Sep, 2018
In an interim order, the Delhi High Court on Tuesday directed that no coercive steps be taken against the sale of 328 fixed dose combination (FDC) drugs that were banned by the government last week but are still available in the market.

The order came on pleas filed by different pharma companies to challenge a Ministry of Health and Family Welfare decision to ban the manufacture, sale and distribution of these FDC drugs with immediate effect.

Justice Vibhu Bakhru said that the interim order would apply to companies that had moved the court and sought the Ministry's reply. The matter was listed for September 27.

It also asked the companies to give the batch numbers of the stock available in the market.

The petitioners included firms like Wockhardt, Glenmark, Obsurge Biotech, Alkem Laboratories, Coral Laboratories, Mankind Pharma, Lupin, Macleods, Laborate and Koye Pharmaceuticals.

The Ministry last week restricted the manufacture, sale and distribution of six FDCs subject to certain conditions, the Ministry said in a statement. The FDCs are two or more drugs combined in a fixed ratio into a single dosage form.

The Centre, in March 2016, had prohibited the manufacture for sale and distribution of 349 FDCs, but it was contested by the affected manufacturers in High Courts and the Supreme Court.

Complying with the December 2017 Supreme Court judgment, the Drugs Technical Advisory Board (DTAB) examined the matter and, in its report to the Centre, recommended prohibition of the FDCs on the ground that there was no therapeutic justification for their ingredients and that these FDCs may involve risks to humans.

Earlier, an expert committee appointed by the Centre too had made similar observations.

Considering the recommendations of DTAB and the expert committee, the Health Ministry, through a gazette notification, prohibited 328 FDCs.